Document Detail

Long-term efficacy and safety of etanercept after readministration in patients with active ankylosing spondylitis.
MedLine Citation:
PMID:  15561737     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: Treatment of ankylosing spondylitis (AS) with the tumour necrosis factor alpha (TNF-alpha) receptor fusion protein etanercept has shown efficacy in patients with active disease in randomized controlled trials (RCTs) for limited periods. The objective of the study was to assess the long-term efficacy and safety of etanercept over 1 yr, including discontinuation and readministration. METHODS: In this 54-week open observational study, 26 AS patients received 25 mg etanercept subcutaneously twice weekly after several months of discontinuation following a 6-month RCT with the same agent. All patients who developed high disease activity after cessation of etanercept, defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) > or = 4 and pain > or = 4 on a numerical rating scale, entered the study. Standard assessment tools, such as the Bath Ankylosing Spondylitis functional index (BASFI), were used. An intention-to-treat (ITT) and a completer analysis were performed. The results were compared with the baseline values of the open study. RESULTS: Out of the initial 30 patients, 26 (87%) were eligible for the open extension study after a mean of about 27 weeks. At week 54, 23/26 patients (88%) were still on treatment with etanercept. The ITT analysis showed that 58% (95% confidence interval 39-74%) of the patients achieved a 50% improvement of BASDAI at week 54. According to the Assessments in Ankylosing Spondylitis working group criteria, 8/26 patients (31%) were in partial remission at week 54. Function, metrology and quality of life improved significantly. Only one patient had a serious adverse event that resulted in discontinuation. CONCLUSIONS: This study shows that treatment with etanercept is efficacious and safe after readministration over 1 yr in patients with active AS not taking DMARDs or steroids.
J Brandt; J Listing; H Haibel; H Sörensen; A Schwebig; M Rudwaleit; J Sieper; J Braun
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2004-11-23
Journal Detail:
Title:  Rheumatology (Oxford, England)     Volume:  44     ISSN:  1462-0324     ISO Abbreviation:  Rheumatology (Oxford)     Publication Date:  2005 Mar 
Date Detail:
Created Date:  2005-02-24     Completed Date:  2005-04-12     Revised Date:  2007-09-06    
Medline Journal Info:
Nlm Unique ID:  100883501     Medline TA:  Rheumatology (Oxford)     Country:  England    
Other Details:
Languages:  eng     Pagination:  342-8     Citation Subset:  AIM; IM    
Department of Gastroenterology/Rheumatology, Charité, Medical University Berlin, Campus Benjamin Franklin, Germany.
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MeSH Terms
Anti-Inflammatory Agents, Non-Steroidal / adverse effects,  therapeutic use
Antirheumatic Agents / adverse effects,  therapeutic use*
Immunoglobulin G / adverse effects,  therapeutic use*
Receptors, Tumor Necrosis Factor / therapeutic use*
Retreatment / methods
Spondylitis, Ankylosing / drug therapy*,  physiopathology
Treatment Outcome
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 0/Antirheumatic Agents; 0/Immunoglobulin G; 0/Receptors, Tumor Necrosis Factor; 185243-69-0/TNFR-Fc fusion protein
Erratum In:
Rheumatology (Oxford). 2005 Apr;44(4):569

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